Bioresearch Monitoring Alert articles from August 2002

Bioresearch Monitoring Alert archives from August 2002

Introduction of limited data sets, lifting of `minimum necessary' concept among changes in HIPAA final rule. (HIPAA).
August 1, 2002... The Bush administration offered some relief to those struggling to meet the April 14, 2003, deadline for the Health Insurance Portability and Accountability Act (HIPAA) privacy rules. The Department of Health and Human Services (HHS) has...

Maryland IRB law has no money for enforcement, but `important step' in accountability attorney says. (IRBs).
August 1, 2002... Maryland's Human Subject Research law, which has raised concerns about state encroachment on the traditional federal oversight of IRBs, will not carry any additional funding for enforcement Health Policy Chief Counsel Jack Schwartz, J.D., of...

Half of all FDA-inspected labs draw 483s, mostly contractors; study directors blamed. (GLPs).
August 1, 2002... PHILADELPHIA -- About half of all FDA inspections for Good Laboratory Practice (GLP) compliance in the past decade wound up with a 483 and 19% of sites had "significant observations," according to a consultant who examined inspections from...

Latin America becomes growing area for clinical trial oversight. (International).
August 1, 2002... CHICAGO -- There is no doubt major interest in conducting clinical studies in Latin America, and that means BiMo inspections are sure to follow. While most countries south of the Rio Grande do not have active inspection programs due to...

Accreditation a must within five years, industry consultant says. (Human subject protection).
August 1, 2002... Accreditation of clinical investigators and CROs is a prospect that will occur in the next five years, so the biomedical industries ought to be prepared, a noted consultant in medical device trials said Aug. 5. Nancy Stark, Ph.D.,...

Limited data set significant for clinical sites in final HIPAA rule, but Congress could still step in with tougher laws.
August 1, 2002... While the final HIPAA privacy rule gives some reprieve to clinical sites, more pressure on privacy and patient rights could be in store as Congress considers rewriting human research subject protection laws. Benjamin Hayes, an attorney...

Off-label disclosure in informed consent debated at NHRPAC. (Informed consent).
August 1, 2002... Should non-altruistic participants in clinical studies be given informed consent forms advising them against enrolling if they want "what is best to treat" their medical condition? Jerry Menikoff, M.D., of the University of Kansas Medical...

IRB lacks basic knowhow of FDA compliance. (IRBs).
August 1, 2002... ImmunoGenetics Investigational Review Board, Birmingham, AL, New Orleans District As bodies charged with overseeing clinical trials, IRBs must be well-versed in federal regulations. However, a summer 2001 inspection showed that the...

"Significant deviations" discovered in IRB audit; warning letter issued.
August 1, 2002... AMERICA Charitable Fund National Medical & Research Institute Institutional Review Board, Boca Raton, FL, Florida District The IRB for the AMERICA Charitable Fund National Medical & Research Institute, Boca Raton, FL, took a beating in a...

Error had study subjects on wrong medications. (Clinical investigators).
August 1, 2002... Joseph Ramsdell, M.D., University of California-San Diego Clinical Trials Center, San Diego, CA, Los Angeles District Two subjects in a study administered by Joseph Ramsdell, M.D., were given the wrong treatment drug for roughly three...

Allegations from former employee spark audit.
August 1, 2002... Ira Klimberg, M.D., Urology Center of Florida, Ocala, FL, Florida District Informed consent violations were the focus of a three-page 483 received by clinical investigator Ira Klimberg, M.D., at the close of a March 2001 FDA visit....

FDA deems investigator too hands-off in study conduct.
August 1, 2002... William Patterson, M.D., Birmingham Research Group, Birmingham, AL, New Orleans District Lack of primary investigator involvement brought FDA to the door of William Patterson, M.D., president of the Birmingham Research Group, Birmingham,...

BiMo FOIA log.
August 1, 2002... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators, which were filed with FDA under the Freedom of Information Act (FOIA). This list does not...

NIDPOE letters.
August 1, 2002... The following "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain" (NIDPOE) letter was issued by the CDER Office of Medical Policy to the clinical investigator regarding his conduct of clinical studies. This and...

Warning letters.
August 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs release July 15-Aug. 2, 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 9007W,...

IRB determination letters.
August 1, 2002... The following are Compliance Determination Letters for IRBs issued in June and July by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to...